NCT02056171

Efficacy of Quetiapine for Pediatric Delirium

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 1 Year – 22 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.

Detailed description

Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication. Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.

Conditions

• Delirium

Interventions

Type	Name	Description
DRUG	quetiapine	Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
OTHER	Placebo	Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-02-05
• Last updated: 2017-12-13
• Results posted: 2017-12-13

Locations

2 sites across 1 country: United States